1.Xuefu Zhuyutang in Malignant Tumor Disease: A Review
Jiaqi JI ; Xiaoqing HU ; Yihan ZHAO ; Xuhang SUN ; Dandan WEI ; Junwen PEI ; Shiqing JIANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(3):321-330
Cancer has become a significant global public health issue, severely impacting public health and societal development. Despite advances in tumor treatment methods in recent years and a gradual decline in cancer mortality rates, drug-related adverse reactions and drug resistance remain substantial challenges. Traditional Chinese medicine (TCM) has demonstrated significant clinical efficacy in cancer treatment and small side effects, making it widely applied in the field of oncology. Xuefu Zhuyutang, derived from Yilin Gaicuo, is known for its abilities to invigorate blood circulation, dispel blood stasis, promote Qi flow, and alleviate pain. It was specifically formulated by the esteemed WANG Qingren of the Qing dynasty for the "blood stasis syndrome in the blood mansion" and is commonly used to treat Qi stagnation and blood stasis syndrome. Clinical studies have shown that Xuefu Zhuyutang, when combined with conventional Western medications, produces significant effects in the treatment of malignant tumors such as liver cancer, lung cancer, and cervical cancer. It substantially reduces the incidence of adverse reactions following Western treatments, including radiation esophagitis, radiation encephalopathy, radiation-induced oral mucositis, and edema. Additionally, it alleviates cancer-related pain and fever, blood hypercoagulability, and associated complications such as depression and anxiety, and also mitigates chemotherapy-induced side effects like hand-foot syndrome. Basic research has demonstrated its potential anti-tumor mechanisms, including the inhibition of Wnt/β-catenin signaling pathway activation, suppression of mitogen-activated protein kinase (MAPK) pathway activation, and anti-tumor angiogenesis. Pharmacological studies have revealed that its active components inhibit tumor cell proliferation and migration, induce tumor cell apoptosis, suppress tumor angiogenesis, enhance the cytotoxicity of natural killer cells against tumors, improve the tumor microenvironment, and regulate immune function. This paper reviewed the latest research progress on Xuefu Zhuyutang in the treatment of malignant tumors from four aspects: theoretical exploration, clinical studies, mechanisms of action, and pharmacological basis, aiming to provide insights and methods for the clinical diagnosis and treatment of malignant tumors.
2.Xuefu Zhuyutang in Malignant Tumor Disease: A Review
Jiaqi JI ; Xiaoqing HU ; Yihan ZHAO ; Xuhang SUN ; Dandan WEI ; Junwen PEI ; Shiqing JIANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(3):321-330
Cancer has become a significant global public health issue, severely impacting public health and societal development. Despite advances in tumor treatment methods in recent years and a gradual decline in cancer mortality rates, drug-related adverse reactions and drug resistance remain substantial challenges. Traditional Chinese medicine (TCM) has demonstrated significant clinical efficacy in cancer treatment and small side effects, making it widely applied in the field of oncology. Xuefu Zhuyutang, derived from Yilin Gaicuo, is known for its abilities to invigorate blood circulation, dispel blood stasis, promote Qi flow, and alleviate pain. It was specifically formulated by the esteemed WANG Qingren of the Qing dynasty for the "blood stasis syndrome in the blood mansion" and is commonly used to treat Qi stagnation and blood stasis syndrome. Clinical studies have shown that Xuefu Zhuyutang, when combined with conventional Western medications, produces significant effects in the treatment of malignant tumors such as liver cancer, lung cancer, and cervical cancer. It substantially reduces the incidence of adverse reactions following Western treatments, including radiation esophagitis, radiation encephalopathy, radiation-induced oral mucositis, and edema. Additionally, it alleviates cancer-related pain and fever, blood hypercoagulability, and associated complications such as depression and anxiety, and also mitigates chemotherapy-induced side effects like hand-foot syndrome. Basic research has demonstrated its potential anti-tumor mechanisms, including the inhibition of Wnt/β-catenin signaling pathway activation, suppression of mitogen-activated protein kinase (MAPK) pathway activation, and anti-tumor angiogenesis. Pharmacological studies have revealed that its active components inhibit tumor cell proliferation and migration, induce tumor cell apoptosis, suppress tumor angiogenesis, enhance the cytotoxicity of natural killer cells against tumors, improve the tumor microenvironment, and regulate immune function. This paper reviewed the latest research progress on Xuefu Zhuyutang in the treatment of malignant tumors from four aspects: theoretical exploration, clinical studies, mechanisms of action, and pharmacological basis, aiming to provide insights and methods for the clinical diagnosis and treatment of malignant tumors.
3.Investigation of focal spatial patterns and symptom mapping in acute ischemic stroke of different etiologies
Yi ZHOU ; Qiang XU ; Min CAO ; Liang JIANG ; Dajing WANG ; Xiaoqing CHENG ; Jianrui LI ; Wusheng ZHU ; Xindao YIN ; Zhiqiang ZHANG
Chinese Journal of Radiology 2025;59(6):688-695
Objective:To investigate the impact of different etiologies on the spatial distribution pattern of infarcts and the mapping pattern of focal symptoms in acute ischemic stroke (AIS) using a population-based standardized spatial analysis of MRI.Methods:This was a cross-sectional study. Clinical [age, sex distribution, admission National Institutes of Health Stroke Scale (NIHSS) score and 90-day modified Rankin Scale (mRS) score at discharge, etc.] and imaging data of 2 610 patients with AIS attending 9 Medical Centers from January 2015 to December 2021 were retrospectively analyzed. All patients were categorized into 1 718 cases of large artery atherosclerosis (LAA) type, 335 cases of cardioembolism (CE) type, and 557 cases of small artery occlusion (SAO) type according to TOAST typing. All patients underwent diffusion-weighted imaging, and the detected infarct lesions were segmented and aligned to the standardized space using artificial intelligence-assisted methods, and the spatial distribution frequency heatmaps of lesion locations in patients with different TOAST subtypes were plotted and compared with each other by χ2 test. Lesion-symptom image brain maps with different clinical symptoms were further plotted, and differences of lesion-symptom image relationships among different TOAST subtypes were observed and compared with each other by interaction effect. Results:In all patients, the favored sites of infarct lesions were the bilateral middle cerebral artery region in the anterior circulation and the occipital and brainstem regions in the posterior circulation. Compared with the LAA type, the CE type lesions were more likely to occur in the anterior cerebral artery region, the occipital lobe, and the cerebellum posterior, while the SAO type lesions were more likely to occur in the perforator artery supply area. The lesion-symptom mapping results showed that AIS patients with infarct lesions in the frontoparieto-temporal region in the presence of a left middle cerebral artery supply had higher admission NIHSS scores and higher discharge 90-day mRS scores for the LAA type than for the CE type( P<0.05); AIS patients with infarcted lesions in the brainstem region and some cerebellar regions in the presence of vertebrobasilar artery supply had higher admission NIHSS scores and higher discharge 90-day mRS scores for the CE type than for the LAA type( P<0.05). Conclusion:At the population level, brain mapping reveals specific infarct distribution patterns and differences in lesion-symptom mapping patterns of different etiologies AIS patients, providing imaging evidence for the understanding of AIS pathogenetic mechanisms and clinical management.
4.Association of peripheral blood glucose 6 phosphate dehydrogenase,progranulin and neutrophil CD64 index with disease outcomes of neonates with septicemia
Congcong ZHU ; Xiaochun CHEN ; Huai JIANG ; Zhendi XIE ; Xiaoqing LIN
Chinese Journal of Nosocomiology 2025;35(6):918-922
OBJECTIVE To explore the association of peripheral blood glucose 6 phosphate dehydrogenase(G6PD),progranulin(PGRN)and neutrophil CD64 index with the disease outcomes of the neonates with septicemia.METHODS A total of 147 neonates with septicemia who were treated in the Second Affiliated Hospital of Wenzhou Medical University from Jun.2021 to Nov.2023 were assigned as the septicemia group,meanwhile,140 healthy neonates were chosen as the healthy group.The neonates of the septicemia group were divided into the early-onset group and the late-onset group according to the type of disease,the non-critically severe group,the critically se-vere group and the extremely critically severe group according to the severity of diseases,the survival group and the death group according to 30-day prognosis.The levels of peripheral blood G6PD,PGRN and neutrophil CD64 indexes were observed and compared among the various types of groups,and the values of the peripheral blood in-dexes in prediction of the prognosis were analyzed.RESULTS The peripheral blood G6PD level of the septicemia group was significantly lower than that of the healthy group,the levels of PGRN and neutrophil CD64 index of the septicemia group were significantly higher than those of the healthy group(P<0.05).As compared with the pe-ripheral blood G6PD level among the neonates with different illness condition,the result was as follows:the non-critically severe group>the critically severe group>the extremely critically severe group(P<0.05);as com-pared with the levels of PGRN and neutrophil CD64 index,the result was as follows:the non-critically severe group<the critically severe group<the extremely critically severe group(P<0.05).The peripheral blood G6PD level of the death group was significantly lower than that of the survival group(P<0.05),and the levels of PGRN and neutrophil CD64 index of the death group were significantly higher than those of the survival group(P<0.05).The area under the curve(AUC)of the joint detection of peripheral blood G6PD,PGRN and CD64 index was 0.831 in prediction of the prognosis of the neonates,significantly higher than that of the single detection of the three indexes(P<0.05).CONCLUSIONS The neonates with septicemia show the decline of peripheral blood G6PD and the rise of levels of PGRN and CD64 index.The expression levels of the indexes are associated with the severi-ty of disease and,to some extent,can predict the prognosis.
5.Analysis of the current status of red blood cell transfusion in very preterm infants from Chinese Neonatal Network in 2022
Yan MO ; Aimin QIAN ; Ruimiao BAI ; Shujuan LI ; Xiaoqing YU ; Jin WANG ; K. Shoo LEE ; Siyuan JIANG ; Qiufen WEI ; Wenhao ZHOU
Chinese Journal of Pediatrics 2025;63(1):55-61
Objective:To analyze the current status of red blood cell transfusion in very preterm infants (VPI) (gestational age at birth <32 weeks) from Chinese Neonatal Network (CHNN) in 2022.Methods:This cross-sectional study was based on the CHNN VPI cohort. It included 6 985 VPI admitted to CHNN 89 participating centers within 24 hours after birth in 2022. VPI with major congenital anomalies or those transferred to non-CHNN centers for treatment or discharged against medical advice were excluded. VPI were categorized based on whether they received red blood cell transfusions, their gestational age at birth, the type of respiratory support received during transfusion, and whether the pre-transfusion hemoglobin levels exceeded the thresholds. General characteristics, red blood cell transfusion rates, number of transfusions, timing of the first transfusion, and pre-transfusion hemoglobin levels were compared among different groups. The incidence of adverse outcomes between the group of VPI who received transfusions above the threshold and those who received transfusions below the threshold were compared. Comparison among different groups was conducted using χ2 tests, Kruskal-Wallis H tests, Mann-Whitney U test, and so on. Trends by gestational age at birth were evaluated by Cochran-Armitage tests and Jonckheere-Terpstra tests for trend. Results:Among the 6 985 VPI, 3 865 cases(55.3%) were male, with a gestational age at birth of 30.0 (28.6, 31.0) weeks and a birth weight of (1 302±321) g. Overall, 3 617 cases (51.8%) received red blood cell transfusion, while 3 368 cases (48.2%) did not. The red blood cell transfusion rate was 51.8% (3 617/6 985), with rates of 77.7% (893/1 150) for those born before 28 weeks gestational age and 46.7% (2 724/5 835) for those born between 28 and 31 weeks gestational age. A total of 9 616 times red blood cell transfusions were administered to 3 617 VPI, with 632 times missing pre-transfusion hemoglobin data, and 8 984 times included in the analysis. Of the red blood cell transfusions, 25.6% (2 459/9 616) were administered when invasive respiratory support was required, 51.3% (4 934/9 616) were receiving non-invasive respiratory support, while 23.1% (2 223/9, 616) were given when no respiratory support was needed. Compared to the non-transfusion group, the red blood cell transfusion group had a higher rate of pregnancy-induced hypertension in mothers, lower rates of born via cesarean section and mother′s antenatal steroid administration, smaller gestational age, lower birth weight, a higher proportion of small-for-gestational-age, multiple births, and proportions of Apgar score at the 5 th minute after birth ≤3 (all P<0.05). They were also less likely to be female, born in hospital or undergo delayed cord clamping (all P<0.01). Additionally, higher transport risk index of physiologic stability score at admission were observed in the red blood cell transfusion group ( P<0.001). The number of red blood cell transfusion was 2 (1, 3) times, with the first transfusion occurring at an age of 18 (8, 29) days, and a pre-transfusion hemoglobin level of 97 (86, 109) g/L. For VPI ≤7 days of age, the pre-transfusion hemoglobin levels for invasive respiratory support, non-invasive respiratory support, or no respiratory support, respectively, with no statistically significant differences between groups ( H=5.59, P=0.061). For VPI aged 8 to 21 days and≥22 days, the levels with statistically differences between groups (both P<0.01). Red blood cell transfusions above recommended thresholds were observed in all respiratory support categories at different stages of life, with the highest prevalence in infants aged 8 to 21 days and≥22 days who did not require respiratory support, at 90.1% (264/273) and 91.1%(1 578/1 732), respectively. The rate of necrotizing enterocolitis was higher in the above-threshold group ( χ2=10.59, P=0.001), and the duration of hospital stay was longer in the above-threshold group ( Z=4.67, P<0.001) compared to the below-threshold group. Conclusions:In 2022, the red blood cell transfusion rate was relatively high among VPI from CHNN. Pre-transfusion hemoglobin levels frequently exceeded recommended transfusion thresholds.
6.Prevalence of Schistosoma japonicum infections in wild rodents in key areas during the elimination phase
Chao LÜ ; Xiaojuan XU ; Jiajia LI ; Ting FENG ; Hai ZHU ; Yifeng LI ; Ling XU ; Zhihong FENG ; Huiwen JIANG ; Xiaoqing ZOU ; Wenjun WEI ; Zhiqiang QIN ; Yang HONG ; Shiqing ZHANG ; Jing XU
Chinese Journal of Schistosomiasis Control 2025;37(5):475-481
Objective To investigate the prevalence of Schistosoma japonicum infections in wild rodents in schistosomiasis-endemic areas of China, so as to provide insights into formulation of technical guidelines for monitoring of and the precise control strategy for S. japonicum infections in wild rodents during the elimination phase. Methods Two administrative villages where schistosomiasis was historically highly prevalent were selected each from Dongzhi County, Anhui Province, and Duchang County, Jiangxi Province as study villages. Wild rodents were captured from study villages with baited traps or cages at night in June and September, 2021. The number of rodents captured was recorded, and the rodent species was characterized based on morphologi-cal characteristics. Liver tissues were sampled from captured rodents for macroscopical observation of the presence of egg granu- lomas, and S. japonicum infection was detected simultaneously using liver tissue homogenate microscopy, examinations of mesenteric tissues for parasites, and modified Kato-Katz thick smear technique (Kato-Katz technique). A positive S. japonicum infection was defined as detection of S. japonicum eggs or adult worms by any of these methods. The rate of wild rodent capture and prevalence of S. japonicum infections in wild rodents were compared in different study villages and at different time periods, and the detection of S. japonicum infections in wild rodents was compared by different assays. Results The overall rate of wild ro- dent capture was 8.28% (237/2 861) in Dongzhi County, and the wild rodent capture rates were 9.24% (133/1 439) and 7.31% (104/1 422) in two study villages (χ2 = 3.503, P = 0.061), and were 8.59% (121/1 409) and 7.99% (116/1 452) in June and September, 2021, respectively (χ2 = 0.337, P = 0.561). The overall rate of wild rodent capture was 3.72% (77/2 072) in Duchang County, and the wild rodent capture rates were 6.91% (67/970) and 0.91% (10/1 102) in two study villages (χ2 = 51.901, P < 0.001), and were 4.13% (39/945) and 3.37% (38/1 127) in June and September, 2021, respectively (χ2 = 0.815, P = 0.365). Rattus norvegicus was the predominant rodent species captured in both counties, accounting for 70.04% (166/237) of all captured wild rodents in Dongzhi County and 88.31% (68/77) in Duchang County. No S. japonicum infection was detected in wild rodents captured in Duchang County. Nevertheless, the overall prevalence of S. japonicum infections was 51.05% (121/237) in wild rodents captured in Dongzhi County, with prevalence rates of 50.38% (67/133) and 51.92% (54/104) in two study villages (χ2 = 0.098, P = 0.755), and 54.31% (63/116) and 47.93% (58/121) in September and June, 2021, respectively (χ2 = 0.964, P = 0.326). Of 237 wild rodents captured in Dongzhi County, there were 140 (59.07%) rodents with visible hepatic egg granulomas, 117 (49.47%) tested positive for S. japonicum eggs by liver tissue homogenate microscopy, 34 (14.35%) tested positive for S. japonicum eggs with Kato-Katz technique; however, no adult S. japonicum worms were detected in mesenteric tissues. In addition, hepatic egg granulomas were found in all wild rodents tested positive for S. japonicum eggs with liver tissue homogenate microscopy. Conclusions The rate of wild rodent capture and prevalence of S. japonicum infection in wild rodents vary greatly in schistosomiasis-endemic areas of China, and the prevalence of S. japonicum infection is slightly higher in wild rodents captured in autumn than in summer. Liver tissue is recommended as the preferred sample for surveillance of S. japonicum infection in wild rodents, and a combination of macroscopical observation of hepatic egg granulomas and liver tissue homogenate microscopy may be a standard method for surveillance of S. japonicum infection in wild rodents.
7.Association Between Obstructive Sleep Apnea and Behavioral Problems in Children
Xin ZHAO ; Wanshu LI ; Jin ZHOU ; Liqiong JIANG ; Xiaomei WANG ; Xiaohua OU ; Xiaoqing ZHANG
Journal of Sichuan University (Medical Sciences) 2025;56(5):1373-1379
Objective To investigate the effect of obstructive sleep apnea(OSA)on behavioral problems in children and the association between them.Methods A simple random sampling method was used to select 100 children aged 4 to 12 years for the case group.All of them were diagnosed with OSA through overnight polysomnography at the Sleep Medicine Center,West China Fourth Hospital,Sichuan University between October 2022 and October 2023.An additional 100 children without snoring symptoms and clinically evaluated and confirmed as not having OSA were enrolled as the control group.General demographic data of the participants were collected.The Caregiver Report Form of the Achenbach Child Behavior Checklist(CBCL)was used for behavioral problem assessment,and polysomnography data were collected.The chi-square/t test was used to analyze the inter-group differences in general data,the total score of behavioral problems,and scores for each dimension.Linear regression was performed to analyze the relationship between OSA and the total score for children's behavioral problems and those for the different dimensions.Logistic regression was applied to analyze the relationship between the obstructive apnoea-hypopnea index(OAHI)and behavioral problems in children with OSA.A logistic regression model integrating the OAHI×sex interaction term was constructed to evaluate the moderating effect of sex on the association between OAHI and behavioral problems.Results No significant differences were observed in general demographic data between the case and control groups.The total score for behavioral problems and those for each dimension were higher in the case group than those in the control group,with the total score of the case group being 24.60±1.55 and that of the control group being 8.85±0.75(P<0.001).The results of the linear regression analysis showed a positive association between OSA and both the total score for behavioral problems(b=16.01;95%CI,12.56-19.47)and those for each dimension.The results of the logistic regression analysis showed that,after adjusting for covariates,OAHI was a risk factor for behavioral problems in children with OSA(odds ratio[OR]=1.17;95%CI,1.04-1.31).After stratification by sex and adjustment for covariates,the OR value of the effect of OAHI on behavioral problems was slightly higher in female participants(1.57)than that in male participants(1.21).The interaction effect analysis showed that sex moderated the association between OAHI and behavioral problems(OR=1.64;95%CI,1.02-2.64;P=0.04).Conclusion Children with OSA are prone to developing behavioral problems.OAHI is a risk factor for behavioral problems in children with OSA,with a potentially greater effect observed in girls.
8.Efficacy and safety of CA280 cytokine adsorption column in treatment of acute-on-chronic liver failure
Yan HE ; Dakai GAN ; Xiaoqing ZHANG ; Tao LONG ; Xuezhen ZHANG ; Wei ZHANG ; Yizhen XU ; Yuyu ZENG ; Rui ZHOU ; Shuanglan LIU ; Xizi JIANG ; Yushi LU ; Molong XIONG ; Yunfeng XIONG
Journal of Clinical Hepatology 2025;41(10):2093-2101
ObjectiveTo investigate the application of the novel inflammatory factor adsorption column CA280 combined with low-dose plasma exchange (LPE) in patients with acute-on-chronic liver failure (ACLF). MethodsA prospective cohort study was designed, and a total of 93 ACLF patients who were admitted to The Ninth Hospital of Nanchang from June 2023 to January 2025 were enrolled and randomly divided into DPMAS+LPE group with 50 patients and CA280+LPE group with 43 patients. In addition to comprehensive medical treatment, the patients in the DPMAS+LPE group received DPMAS and LPE treatment, and those in the CA280+LPE group received CA280 and LPE treatment. The two groups were observed in terms of routine blood test results, liver function parameters, renal function markers, electrolytes, coagulation function parameters, cytokines, adverse events, and 28-day prognosis before surgery (baseline), during surgery (DPMAS or CA280), and after surgery (after sequential LPE treatment). The paired t-test was used for comparison of normally distributed continuous data before and after treatment within each group, and the independent-samples t test was used for comparison between groups; the Wilcoxon signed-rank test was used for comparison of non-normally distributed continuous data before and after treatment within each group, and the Mann-Whitney U test was used for comparison between groups. The chi-square test or the Fisher’s exact test was used for comparison of categorical data between groups, and the Spearman test was used for correlation analysis. ResultsAfter CA280 treatment, the ACLF patients had significant reductions in the levels of cytokines (IL-6, IL-8, IL-10, TNF-α, and IFN-γ), liver function parameters (ALT, AST, ALP, TBil, DBil, Alb, and glutathione reductase), and the renal function marker urea nitrogen (all P<0.05), and in terms of coagulation function parameters, there were significant increases in prothrombin time, activated partial thromboplastin time (APTT), thrombin time, and international normalized ratio (INR) and significant reductions in prothrombin activity (PTA) and fibrinogen (FIB) (all P<0.05). Compared with the DPMAS+LPE group, the CA280+LPE group showed better improvements in the serum cytokines IL-8 (Z=-2.63, P=0.009), IL-10 (Z=-3.94, P<0.001), and TNF-α (Z=-1.53, P=0.023), and the two artificial liver support systems had a similar effect in improving liver function (ALT, AST, GGT, GR, TBil, and DBil) (all P >0.05), but the CA280+LPE group showed a significantly greater reduction in Alb (Z=-2.08, P=0.037). CA280+LPE was more effective in reducing uric acid (Z=-2.97, P=0.003). Compared with DPMAS+LPE, CA280+LPE treatment resulted in a significant reduction in INR (Z=-4.01, P<0.001), a significant increase in APTT (Z=-2.53, P=0.011), and significant greater increases in PTA (Z=-6.28, P<0.001) and FIB (Z=-3.93, P<0.001). There were no significant differences in the incidence rates of adverse reactions and the rate of improvement at discharge between the two groups (all P>0.05). The Spearman correlation analysis showed that IL-6 was significantly correlated with WBC (r=0.22, P=0.042), TBil (r=0.29, P=0.005), and FIB (r=-0.33, P=0.003); IL-8 was positively correlated with APTT (r=0.37, P<0.001) and INR (r=0.25, P=0.013); TNF-α was significantly correlated with WBC (r=0.40, P<0.001) and TBil (r=0.34, P<0.001). ConclusionCompared with DPMAS, CA280 combined with LPE can effectively clear proinflammatory cytokines and improve liver function in ACLF patients, but it has a certain impact on Alb and coagulation function. This regimen provides a new option for the individualized treatment of ACLF and can improve the short-term prognosis of patients, but further studies are needed to verify its long-term efficacy.
9.Comparison of clinical outcomes among different endoscopic myotomy techniques for achalasia
Yingfan LI ; Tao GUO ; Xiaoqing LI ; Yaowen HU ; Xi WU ; Qingwei JIANG ; Aiming YANG
Chinese Journal of Digestive Endoscopy 2025;42(8):616-621
Objective:To compare the clinical efficacy and safety of different myotomy procedures during peroral endoscopic myotomy (POEM) for achalasia (AC).Methods:A retrospective study was conducted involving patients diagnosed as having achalasia and underwent POEM at Peking Union Medical College Hospital from April 2020 to October 2023. Patients were divided into conventional myotomy group, short myotomy group and full-thickness myotomy group according to myotomy length and depth. Outcomes including operation duration, procedure-related complications, efficacy and incidence of postoperative reflux esophagitis were compared between conventional vs. short, and conventional vs. full-thickness groups.Results:Among 70 patients, 26 underwent conventional myotomy, 19 short myotomy, and 25 full-thickness myotomy. The short myotomy group demonstrated significantly shorter procedure duration (72.89±20.57 min) compared to the conventional group (91.81±36.70 min, t=2.197, P=0.034). There were no statistically significant differences in procedure-related complications [26.3% (5/19) VS 34.6% (9/26), χ2=0.353, P=0.553], treatment efficacy [94.7% (18/19) VS 96.2% (25/26), χ2=0.052, P=0.820], or incidence of postoperative reflux esophagitis [50.0% (5/10) VS 41.7% (5/12), χ2=0.306, P=0.580] between the short and conventional myotomy groups. No statistically significant differences were observed between the conventional and full-thickness myotomy group in procedure duration (99.64±29.13 min VS 91.81±36.70 min, t=0.336, P=0.404), procedure-related complications [28.0% (7/25) VS 34.6% (9/26), χ2=0.259, P=0.611], treatment efficacy [96.0% (24/25) VS 96.2% (25/26), χ2=0.001, P=0.977], or incidence of postoperative reflux esophagitis [35.7% (5/14) VS 41.7% (5/12), χ2=0.022, P=0.883]. Conclusion:Short myotomy POEM achieves comparable efficacy to conventional myotomy with reduced operative time and no increased complication risk. Full-thickness myotomy demonstrates similar efficacy, operative duration, and safety to conventional myotomy.
10.The efficacy and safety of nebulized inhalation of recombinant human interferon α1b in the treatment of pediatric respiratory syncytial viral associated lower respiratory tract infections: a multicenter, randomized, double-blind, placebo-controlled phase Ⅲ clinical study
Xiaohui LIU ; Baoping XU ; Yunxiao SHANG ; Han ZHANG ; Zhenkun ZHANG ; Guangyu LIN ; Ju YIN ; Aihua CUI ; Guocheng ZHANG ; Zhaoling SHI ; Liwei GAO ; Chunming JIANG ; Junmei BIAN ; Yongjian HUANG ; Rongfang ZHANG ; Xiaomei LIU ; Xiaoqing YANG ; Yu TANG ; Lili ZHONG ; Hongmei QIAO ; Chuangli HAO ; Yuqing WANG ; Qubei LI ; Ling CAO ; Yungang YANG ; Ling LU ; Rongjun LIN ; Xingzhen SUN ; Wei ZHOU ; Qiang CHEN ; Jikui DENG ; Yuejie ZHENG ; Lin ZHAO ; Tao AI ; Xiaohong LIU ; Xiaoxia LU ; Ning JIANG ; Ming LI
Chinese Journal of Applied Clinical Pediatrics 2025;40(3):180-186
Objective:To evaluate the efficacy and safety of nebulized inhalation of recombinant human interferon (IFN) α1b injection in the treatment of respiratory syncytial virus (RSV) associated lower respiratory tract infections (pneumonia and bronchiolitis) in children.Methods:A randomized, double-blind, parallel, placebo-controlled add-on design was used.Children with pneumonia or bronchiolitis aged 2 months to 5 years who tested positive for RSV antigen within 72 hours of onset from 30 clinical trial sites including Beijing Children′s Hospital, Capital Medical University between February 2021 and December 2022 were included in this study and randomly divided into 2 groups at a ratio of 1∶1 based on a stratified-block method.Both groups received basic treatments such as cough control, asthma relieving, expectorant treatment, fever reduction, oxygen therapy, etc.The experimental group received additional nebulized inhalation of IFN α1b injection at a dose of 2.0 μg/(kg·time), twice a day.The control group received nebulized inhalation of placebo twice a day.Clinical efficacy was evaluated based on indicators such as the duration of clinical symptoms and signs, and the Kaplan-Meier method was used to calculate the median and 95% CI of the duration of clinical symptoms and signs.The Log-rank test was used to compared data between groups.Safety was assessed through the incidence of adverse reactions and laboratory tests, and the Chi-square test was used to analyze the difference between groups. Results:There were 123 children in the experimental group and 122 children in the control group.The median durations of all the 5 clinical symptoms and signs [including shortness of breath, wheezing, dyspnea (visible retractions), decreased transcutaneous oxygen saturation, and abnormal mental state] in the experimental group after treatment were slightly shortened than those in the control group [2.7 d(95% CI: 1.9-3.0 d)] vs.[2.9 d(95% CI: 2.6-3.6 d), P=0.027].The improvement in dyspnea (retractions) was especially pronounced in the experimental group, with a relief rate of 50.0% (0, 100%) on the first day of administration[compared with 0 (0, 50.0%) in the control group ( Z=2.002, P=0.025)].The median duration of dyspnea in the experimental group was nearly 1 day shorter than that in the control group [1.0 d(95% CI: 0.7-1.7 d) vs.1.8 d(95% CI: 1.0-2.5 d), P=0.046].There were no significant difference in hospital stay [6.0(5.0, 8.0) d vs.6.5(5.0, 8.0) d, Z=0.675, P=0.500], oxygen therapy duration [32.0(14.0, 96.3) h vs.39.0 (24.0, 83.2) h, Z=0.094, P=0.925], the recovery rate from clinical symptoms during treatment [(105/106, 99.1%) vs.(96/101, 95.0%)], and recurrence rate [(0/106, 0) vs.(2/101, 2.0%)] between the 2 groups (all P>0.05).However, the above-mentioned four indicators in the experimental group showed a trend of clinical benefits.The quantitative virus detection results showed that the RSV viral load in both groups decreased after treatment compared to before treatment.After 2 days of treatment, the decline rate of RSV viral load from the baseline was 0.90 lg copies/(mL·d) in the experimental group and 0.25 lg copies/(mL·d)in the control group, with a statistically significant difference ( P<0.05).Furthermore, there was no statistically significant difference in the incidence of adverse reactions between the 2 groups ( P>0.05).Importantly, no drug-related serious adverse reactions occurred in both groups. Conclusions:The nebulized inhalation therapy of IFN α1b demonstrates efficacy and safety in treating pediatric RSV associated lower respiratory tract infections.It particularly offers outstanding clinical therapeutic value for severe children.

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